Protocol for a bandit-based response adaptive trial to evaluate the effectiveness of brief self-guided digital interventions for reducing psychological distress in university students: the Vibe Up study

IntroductionMeta-analytical evidence confirms a range of interventions, including mindfulness, physical activity and sleep hygiene, can reduce psychological distress in university students. However, it is unclear which intervention is most effective. Artificial intelligence (AI)-driven adaptive tria...

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Published in:	BMJ open Vol. 13; no. 4; p. e066249
Main Authors:	Huckvale, Kit, Hoon, Leonard, Stech, Eileen, Newby, Jill M, Zheng, Wu Yi, Han, Jin, Vasa, Rajesh, Gupta, Sunil, Barnett, Scott, Senadeera, Manisha, Cameron, Stuart, Kurniawan, Stefanus, Agarwal, Akash, Kupper, Joost Funke, Asbury, Joshua, Willie, David, Grant, Alasdair, Cutler, Henry, Parkinson, Bonny, Ahumada-Canale, Antonio, Beames, Joanne R, Logothetis, Rena, Bautista, Marya, Rosenberg, Jodie, Shvetcov, Artur, Quinn, Thomas, Mackinnon, Andrew, Rana, Santu, Tran, Truyen, Rosenbaum, Simon, Mouzakis, Kon, Werner-Seidler, Aliza, Whitton, Alexis, Venkatesh, Svetha, Christensen, Helen
Format:	Journal Article
Language:	English
Published:	England British Medical Journal Publishing Group 28-04-2023 BMJ Publishing Group LTD BMJ Publishing Group
Series:	Protocol
Subjects:	Algorithms Anxiety Anxiety disorders Artificial Intelligence Australia Clinical trials Depression & mood disorders Design Humans Hygiene Intervention Mental depression Mental disorders Mental Health Mindfulness Mindfulness - methods Performance evaluation Psychological Distress Randomized Controlled Trials as Topic Sleep Smartphones STATISTICS & RESEARCH METHODS Stress Stress, Psychological - prevention & control Stress, Psychological - psychology Students - psychology Universities University students Australia Clinical trials MENTAL HEALTH Anxiety disorders STATISTICS & RESEARCH METHODS Depression & mood disorders
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Summary:	IntroductionMeta-analytical evidence confirms a range of interventions, including mindfulness, physical activity and sleep hygiene, can reduce psychological distress in university students. However, it is unclear which intervention is most effective. Artificial intelligence (AI)-driven adaptive trials may be an efficient method to determine what works best and for whom. The primary purpose of the study is to rank the effectiveness of mindfulness, physical activity, sleep hygiene and an active control on reducing distress, using a multiarm contextual bandit-based AI-adaptive trial method. Furthermore, the study will explore which interventions have the largest effect for students with different levels of baseline distress severity.Methods and analysisThe Vibe Up study is a pragmatically oriented, decentralised AI-adaptive group sequential randomised controlled trial comparing the effectiveness of one of three brief, 2-week digital self-guided interventions (mindfulness, physical activity or sleep hygiene) or active control (ecological momentary assessment) in reducing self-reported psychological distress in Australian university students. The adaptive trial methodology involves up to 12 sequential mini-trials that allow for the optimisation of allocation ratios. The primary outcome is change in psychological distress (Depression, Anxiety and Stress Scale, 21-item version, DASS-21 total score) from preintervention to postintervention. Secondary outcomes include change in physical activity, sleep quality and mindfulness from preintervention to postintervention. Planned contrasts will compare the four groups (ie, the three intervention and control) using self-reported psychological distress at prespecified time points for interim analyses. The study aims to determine the best performing intervention, as well as ranking of other interventions.Ethics and disseminationEthical approval was sought and obtained from the UNSW Sydney Human Research Ethics Committee (HREC A, HC200466). A trial protocol adhering to the requirements of the Guideline for Good Clinical Practice was prepared for and approved by the Sponsor, UNSW Sydney (Protocol number: HC200466_CTP).Trial registration numberACTRN12621001223820.
Bibliography:	Protocol ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23 ObjectType-Undefined-3
ISSN:	2044-6055 2044-6055
DOI:	10.1136/bmjopen-2022-066249